The article provides a general overview of the existing legal framework, paying attention to the most important regulatory matters.
Table of content
The Food and Drug Administration (FDA or Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance dedicated to dental composite resin devices in the context of premarket notification [510(k)] submissions. Once finalized, the document will describe the applicable regulatory requirements, and also provide additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.
Regulatory Background
The present draft guidance outlines recommendations for 510(k) submissions specific to dental composite resins utilized in dentistry. These devices are designed to fill and restore defects or carious lesions in teeth.
They may be available as a two-part base and catalyst system that is self-cured or a one-part system cured via photoinitiation. The recommendations in this document are aligned with current review practices, aiming to ensure consistency and streamline the review process of these submissions.
Upon finalization, this draft guidance will replace the guidance titled “Dental Composite Resin Devices — Premarket Notification [510(k)] Submissions” issued on October 26, 2005. This document also complements other FDA guidelines concerning the content requirements and recommendations for a 510(k) submission.
For additional guidance, the applicants should refer to 21 CFR 807.87 and the guidance document “Electronic Submission Template for Medical Device 510(k) Submissions”. The document also contains references to the FDA-recognised voluntary consensus standards medical device manufacturers may use in order to demonstrate compliance with the applicable regulatory requirements, further detailed in the respective guidance document titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices”.
Scope
The scope of this guidance is limited to dental composite resins regulated under 21 CFR 872.3690 and 21 CFR 872.3765, with product codes EBF and EBC.
At the same time, the authority additionally emphasizes that this guidance does not encompass resin restoratives intended for other uses such as cementing, coating, fixation, and temporary restoration (i.e., devices classified in 21 CFR 872.3200; 21 CFR 872.3275; 21 CFR 872.3310; 21 CFR 872.3750; and 21 CFR 872.3770).
It applies to dental composite resins that are combination products, though it does not address specific considerations unique to combination products.
Premarket Submission Recommendations
In order to assist the parties involved, the guidance provides additional clarifications and recommendations to be considered in the context of premarket submissions, outlining the scope of information to be included in order to ensure completeness of the application and facilitate the relevant regulatory procedures in general.
Device Description
It is recommended to identify the device in question by the applicable regulation number and product code indicated in Section II and include the following information:
- A complete description of all formulations, components, and accessories intended to be marketed with the device, including:
- A description of the device’s principle of operation for achieving its intended purpose, such as a description of the curing chemistry and any substances that may be eluted from the device.
- A complete chemical composition for each formulation of the device, including all polymers, monomers, initiators, curing agents, stabilizers, plasticizers, eluting agents, fillers, colorants, and other additives. The quantification of these substances should total 100 percent by mass.
- Descriptions of any accessories packaged with the device, such as dispensers, mixing tips, and mixing pads.
- Labeled images and/or illustrations of all components or accessories included as part of the packaged device.
- Identification of the 510(k) clearance status (including the 510(k) number, if available) of any accessory devices to be used or packaged with the device, if applicable.
Conclusion
In summary, the present draft guidance is intended to assist in the preparation of 510(k) submissions for dental composite resins. It reflects current review practices and aims to facilitate a consistent and efficient review process. The scope of this guidance is specific to dental composite resins regulated under certain CFR sections and does not cover other types of resin restoratives or combination products. The recommendations provided should be viewed as suggestions to ensure compliance with regulatory standards, promoting safety and efficacy in dental treatments.
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